Portuguese Observational Survey to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon by Using Elements of the BetaPlus Program - Nurse Support, Auto-injectors (POR-BetaPlus)

This is an observational survey to assess the factors that influence adherence to Betaferon therapy in multiple sclerosis patients using elements of the BetaPlus support program, including the nurse support and auto-injectors. The patients were evaluated under normal clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping processes (WCQ) and depression questionnaire CES-D.

Identification of reasons why patients are switched from other disease modifying drugs to Betaferon due to perceived lack of efficacy, adverse events, poor compliance, and others. [ Time Frame: After 2 years ] [ Designated as safety issue: No ]

Assessment of factors predictive of non-adherence to disease modifying drugs such as demographic data, course of disease, drug history, patients characteristics, history of poor compliance to prior therapy or others. [ Time Frame: After 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of impact of supportive elements of the BetaPlus Program like nurse support, auto-injector, website, etc on treatment adherence. [ Time Frame: After 2 years ] [ Designated as safety issue: No ]

Evaluation of impact of Betaferon treatment on health related quality of life using the Functional Assessment of Multiple Sclerosis Questionnaire - FAMS. [ Time Frame: After 2 years ] [ Designated as safety issue: No ]

Assessment of coping processes by applying the Ways of Coping Questionnaire. [ Time Frame: After 2 years ] [ Designated as safety issue: No ]

Measurement of safety of Betaferon by assessing the number of participants with adverse events and severe adverse events. Classification by MedDRA category. [ Time Frame: After 2 years ] [ Designated as safety issue: Yes ]

Adjustment of disease modifying treatment necessary at the discretion of the investigator

Switch to Betaferon at least 1 month but not longer than 3 months prior to inclusion

Exclusion Criteria:

Patients not fulfilling the indications in the local prescribing information

Refusal to sign inform consent

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01235455